Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Rituxan (rituximab) for the treatment of pemphigus vulgaris.
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AstraZeneca announced that two pivotal Phase 3 registrational trials for benralizumab achieved their primary endpoint, demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo.
GlaxoSmithKline announced that the primary endpoint for its Phase 3 study of mepolizumab was met for the reduction in the frequency of exacerbations, in patients with severe eosinophilic asthma.
Merck announced data for its investigational Timothy grass sublingual allergy immunotherapy tablet (MK-7243) to treat the underlying cause of allergic rhinitis.
Soligenix announced today that the FDA has designated its OrbShield (oral beclomethasone 17, 21-dipropionate or oral BDP) development program for the treatment of Gastrointestinal Acute Radiation Syndrome (GI ARS), for Fast Track review.
Soligenix announced that the FDA has granted Orphan Drug Designation to OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) for the prevention of death following a potentially lethal dose of total body irradiation (TBI) during or after a radiation disaster.
Soligenix announced that SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) has received Fast Track designation from the FDA for the induction treatment of mild-to-moderate pediatric Crohn’s disease.
Santarus announced results from its CORE I clinical study, one of two of the company’s pivotal Phase 3 clinical studies with Uceris (budesonide) in ulcerative colitis.
Santarus, Inc. announced that the FDA has accepted its New Drug Application (NDA) for Uceris (budesonide) tablets 9mg for the induction of remission of mild to moderate active ulcerative colitis.
Novartis announced data from its Phase 3 study of ACZ885 (canakinumab) for the treatment of children with active systemic juvenile idiopathic arthritis (SJIA).